Medical devices
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2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm Potential for detachment of a distal tip component of the device during use. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm Potential for detachment of a distal tip component of the device during use. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm Potential for detachment of a distal tip component of the device during use. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm Potential for detachment of a distal tip component of the device during use. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Soft-Vu Angiographic Catheter, Pigtail, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft -Vu Angiographic Catheter, Kumpe, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Pigtail, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Berenstein, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Cobra The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Kumpe, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Berenstein, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Cobra The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Cobra The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Kumpe, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Sos Omni Selective The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Headhunter The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Straight Art, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soft-Vu Angiographic Catheter, Kumpe, Non-Braided The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M,… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO… Unapproved design changes to the products outside of the 510(k) clearance. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1)(2) LeadCare¿ II Blood Lead Test Kit Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LeadCare¿ Plus Blood Lead Test Kit Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LeadCare Ultra Blood Lead Test Kit Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm Potential for product to contain foreign matter, confirmed to be inspect fragments. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss… Products were incorrectly labeled with a 5-year shelf life. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, District of Columbia, Kansas, Maryland, North Carolina, New York, Texas and Wisconsin named
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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